Model Number N/A |
Device Problem
Appropriate Term/Code Not Available (3191)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Report source, foreign - event occurred in the (b)(6).Surgeon didn't approve for return.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It has been reported by the hospital that a patient underwent an initial partial knee arthroplasty.Subsequently, patient was revised due to bearing wear.
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Event Description
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It has been reported by the hospital that a patient underwent an initial partial knee arthroplasty.Subsequently, patient was revised due to bearing wear.
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Manufacturer Narrative
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(b)(4).Reported event was unable to be confirmed due to limited information received from the customer.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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